BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964016163·Endo Carry-On Procedure Kit

    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

    FDA Enforcement
    Class II ·Terminated·GF Health Products, Inc·December 21, 2016

    Eagle No Drift

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746061400·EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG

    Eagle No Drift

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746134098·EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG

    Eagle No Drift

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746007651·EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG

    LIFEPAK® 15 monitor/defibrillator

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873871836·15AABBAABABBBAAAAAAAAAAFLP15 MONITOR/DEFIB

    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

    FDA Recall
    Terminated ·GF Health Products, Inc·Product code FNL·September 30, 2016

    KAWASUMI LABORATORY BLOOD DRAWING KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    CEMEX SYSTEM GUN APPLICATION VERSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013

    COULTER® LH750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·February 27, 2011

    TRANSEND 300 GUIDEWIRE

    FDA Adverse Event
    Injury ·NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP·Product code DQX·February 20, 2008

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·February 18, 2016

    PENUMBRA COIL DETACHMENT HANDLE

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·February 18, 2016

    PENUMBRA COIL DETACHMENT HANDLE

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·February 19, 2016

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021